RU2020128269A - HIGHLY STABLE THYROID HORMONE DOSAGE FORMS IN SOFT CAPSULES - Google Patents

HIGHLY STABLE THYROID HORMONE DOSAGE FORMS IN SOFT CAPSULES Download PDF

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Publication number
RU2020128269A
RU2020128269A RU2020128269A RU2020128269A RU2020128269A RU 2020128269 A RU2020128269 A RU 2020128269A RU 2020128269 A RU2020128269 A RU 2020128269A RU 2020128269 A RU2020128269 A RU 2020128269A RU 2020128269 A RU2020128269 A RU 2020128269A
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RU
Russia
Prior art keywords
weight
soft capsule
filler
range
capsule according
Prior art date
Application number
RU2020128269A
Other languages
Russian (ru)
Inventor
Симоне КАРУЧЧИ
Маурицио МАРКЬОРРИ
Марко ПОНТИДЖА
Тициано ФОССАТИ
Original Assignee
Альтергон С.А.
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Application filed by Альтергон С.А. filed Critical Альтергон С.А.
Publication of RU2020128269A publication Critical patent/RU2020128269A/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4883—Capsule finishing, e.g. dyeing, aromatising, polishing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)

Claims (14)

1. Мягкая капсула, содержащая внутри наполнитель, где указанный наполнитель содержит один или более тиреоидных гормонов и высокоамилозный крахмал, где указанный высокоамилозный крахмал содержит амилозу в пределах от 50 до 85% по массе от общей массы крахмала.1. Soft capsule containing inside the filler, where the specified filler contains one or more thyroid hormones and high amylose starch, where the specified high amylose starch contains amylose in the range from 50 to 85% by weight of the total mass of starch. 2. Мягкая капсула по п. 1, в которой количество высокоамилозного крахмала находится в пределах от 10 до 50% по массе от массы наполнителя.2. A soft capsule according to claim 1, wherein the amount of high amylose starch is in the range of 10 to 50% by weight based on the weight of the filler. 3. Мягкая капсула по п. 2, в которой количество высокоамилозного крахмала находится в пределах от 15 до 45% по массе от общей массы наполнителя. 3. A soft capsule according to claim 2 wherein the amount of high amylose starch is in the range of 15 to 45% by weight based on the total weight of the filler. 4.Мягкая капсула по любому из предшествующих пунктов, в которой указанный наполнитель дополнительно содержит один или более растительных гидроколлоидов. 4. A soft capsule according to any one of the preceding claims, wherein said excipient further comprises one or more vegetable hydrocolloids. 5. Мягкая капсула по п. 4, в которой растительный гидроколлоид выбран из ксантана, каррагинана или их смеси. 5. The soft capsule of claim 4, wherein the vegetable hydrocolloid is selected from xanthan, carrageenan, or mixtures thereof. 6. Мягкая капсула по п. 5, в которой растительный гидроколлоид содержит каррагинан в пределах 0,05-5% по массе от массы наполнителя. 6. Soft capsule according to claim 5, in which the vegetable hydrocolloid contains carrageenan in the range of 0.05-5% by weight of the weight of the filler. 7. Мягкая капсула по п. 6, в которой растительный гидроколлоид содержит каррагинан в пределах 0,2-3% по массе от массы наполнителя. 7. Soft capsule according to claim. 6, in which the vegetable hydrocolloid contains carrageenan in the range of 0.2-3% by weight of the weight of the filler. 8. Мягкая капсула по п. 4, в которой растительный гидроколлоид содержит ксантан в пределах 0,03-3% по массе от общей массы наполнителя. 8. Soft capsule according to claim. 4, in which the vegetable hydrocolloid contains xanthan in the range of 0.03-3% by weight of the total weight of the filler. 9. Мягкая капсула по п. 8, в которой растительный гидроколлоид содержит ксантан в пределах 0,05-2% по массе от общей массы наполнителя. 9. Soft capsule according to claim 8, in which the vegetable hydrocolloid contains xanthan in the range of 0.05-2% by weight of the total weight of the filler. 10. Мягкая капсула по любому из предшествующих пунктов, в которой указанный наполнитель содержит глицерин.10. A soft capsule according to any one of the preceding claims, wherein said excipient contains glycerin. 11. Мягкая капсула по п. 10, в которой глицерин содержится в пределах 12-45% по массе от массы наполнителя. 11. Soft capsule according to claim 10, in which glycerin is contained in the range of 12-45% by weight of the weight of the filler. 12. Мягкая капсула по п. 11, в которой глицерин содержится в пределах 20-40% по массе от массы наполнителя. 12. Soft capsule according to claim 11, in which glycerin is contained in the range of 20-40% by weight of the weight of the filler. 13. Способ лечения и/или профилактики заболеваний и/или физиологических состояний, требующих назначения тиреоидных гормонов, включающий введение мягкой капсулы по любому из пп. 1-12 пациенту, который в этом нуждается. 13. A method for the treatment and/or prevention of diseases and/or physiological conditions requiring the appointment of thyroid hormones, including the introduction of a soft capsule according to any one of paragraphs. 1-12 to the patient who needs it. 14. Способ получения мягкой капсулы, имеющей оболочку капсулы и наполнитель, как указано в любом из пп. 1-12, включающий: приготовление состава указанного наполнителя, разделение указанного состава на отдельные части, покрытие указанных частей раствором компонентов оболочки капсулы, сушка конечного продукта. 14. The method of obtaining a soft capsule having a capsule shell and a filler, as specified in any of paragraphs. 1-12, including: preparation of the composition of the specified filler, separation of the specified composition into separate parts, coating of the specified parts with a solution of the components of the capsule shell, drying the final product.
RU2020128269A 2018-03-15 2019-03-06 HIGHLY STABLE THYROID HORMONE DOSAGE FORMS IN SOFT CAPSULES RU2020128269A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IT102018000003615 2018-03-15
IT102018000003615A IT201800003615A1 (en) 2018-03-15 2018-03-15 Highly stable formulations of thyroid hormone in soft capsules
PCT/EP2019/055547 WO2019174990A1 (en) 2018-03-15 2019-03-06 Highly stable formulations of thyroid hormone in soft capsules

Publications (1)

Publication Number Publication Date
RU2020128269A true RU2020128269A (en) 2022-04-15

Family

ID=62530409

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2020128269A RU2020128269A (en) 2018-03-15 2019-03-06 HIGHLY STABLE THYROID HORMONE DOSAGE FORMS IN SOFT CAPSULES

Country Status (14)

Country Link
US (1) US11717486B2 (en)
EP (1) EP3764984B1 (en)
CN (2) CN111936119B (en)
CA (1) CA3094384A1 (en)
DK (1) DK3764984T3 (en)
ES (1) ES2898387T3 (en)
HR (1) HRP20211717T1 (en)
HU (1) HUE056416T2 (en)
IT (1) IT201800003615A1 (en)
MA (1) MA51990A (en)
PL (1) PL3764984T3 (en)
PT (1) PT3764984T (en)
RU (1) RU2020128269A (en)
WO (1) WO2019174990A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2022011549A (en) * 2020-03-18 2022-10-13 Scherer Technologies Llc R P Softgel capsules.

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19541128C2 (en) * 1995-10-27 1997-11-27 Henning Berlin Gmbh & Co Stabilized thyroid hormone-containing medicines
US6214376B1 (en) * 1998-08-25 2001-04-10 Banner Pharmacaps, Inc. Non-gelatin substitutes for oral delivery capsules, their composition and process of manufacture
AU2004201566A1 (en) * 1999-07-07 2004-05-06 R. P. Scherer Technologies, Inc. Film Forming Compositions Comprising Modified Starches and Iota-carrageenan and Methods for Manufacturing Soft Capsules Using Same
ATE349204T1 (en) * 2000-11-09 2007-01-15 Celanese Ventures Gmbh SOFT CAPSULES COMPRISING A STARCH MIXTURE WITH A REDUCED BRANCHING DEGREE
ITMI20011401A1 (en) 2001-07-02 2003-01-02 Altergon Sa PHARMACEUTICAL FORMULATIONS FOR THYROID HORMONES
AU2003294244A1 (en) * 2002-11-07 2004-06-03 Advanced Bionutrition Corp. Nutraceuticals and method of feeding aquatic animals
GB0316206D0 (en) * 2003-07-10 2003-08-13 Glaxo Group Ltd Pharmaceutical formulation
CN1820783A (en) * 2005-02-17 2006-08-23 阿尔特贡股份公司 Thyroid hormone medicinal preparation
CN101180097A (en) * 2005-05-26 2008-05-14 症变治疗公司 Novel phosphinic acid-containing thyromimetics
ITMI20112221A1 (en) * 2011-12-05 2013-06-06 Altergon Sa STABLE FORMULATIONS IN JELLY CAPSULES SPRINGS OF PIASTRINICAL ANTI-AGGREGATES, OMEGA-3 FATTY ACIDS AND AMYLOSUS
PE20150597A1 (en) * 2012-08-20 2015-05-06 Merck Patent Gmbh SOLID PHARMACEUTICAL PREPARATION CONTAINING LEVOTHYROXIN

Also Published As

Publication number Publication date
CN111936119B (en) 2024-02-23
HRP20211717T1 (en) 2022-02-18
US11717486B2 (en) 2023-08-08
US20200375909A1 (en) 2020-12-03
EP3764984B1 (en) 2021-08-18
HUE056416T2 (en) 2022-02-28
ES2898387T3 (en) 2022-03-07
MA51990A (en) 2021-04-07
CN118059054A (en) 2024-05-24
EP3764984A1 (en) 2021-01-20
PT3764984T (en) 2021-10-15
WO2019174990A1 (en) 2019-09-19
PL3764984T3 (en) 2022-02-07
CN111936119A (en) 2020-11-13
DK3764984T3 (en) 2021-10-18
CA3094384A1 (en) 2019-09-19
IT201800003615A1 (en) 2019-09-15

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